80 FR 249 pgs. 81233-81234 - Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments; Correction

Type: PRORULEVolume: 80Number: 249Pages: 81233 - 81234
Docket number: [Docket No. FDA-2015-D-3719]
FR document: [FR Doc. 2015-32686 Filed 12-28-15; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version:  PDF Version
Pages: 81233, 81234

[top] page 81233

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. FDA-2015-D-3719]

Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification of public hearing; request for comments; correction.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is correcting a notification of a public hearing entitled "Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments" that appeared in the Federal Register of October 30, 2015 (80 FR 66845). The document announced a public hearing to obtain input on four recently issued draft guidances relating to the regulation of human cells, tissues, or cellular or tissue-based products (HCT/Ps). The document published with conflicting information about who must register for the public hearing. This document corrects that error.

FOR FURTHER INFORMATION CONTACT:

Lori Jo Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION:

In FR Doc. 2015-27703, appearing on pages 66845 and 66847 in the Federal Register of Friday, October 30, 2015, the following corrections are made:

1. On page 66845, in the third column under DATES , the third sentence is revised to read: "Persons seeking to attend (including FDA employees) or to present at the public hearing must register by January 8, 2016."


[top] 2. On page 66847, in the first column under section IV. Attendance and Registration, the third sentence is revised to read: "Individuals who wish to attend (including FDA employees) or present at the public hearing must page 81234 register by sending an email to CBERPublicEvents@fda.hhs.gov on or before January 8, 2016, and provide complete contact information, including name, title, affiliation, address, email, and phone number."

Dated: December 21, 2015.

Leslie Kux,

Associate Commissioner for Policy.

[FR Doc. 2015-32686 Filed 12-28-15; 8:45 am]

BILLING CODE 4164-01-P